IMN Diameter to Femoral Canal Diameter and Union

NCT04195334 | Unknown

• 1 other identifier: IMN diameter and union
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

To Detect the Relation Between the Intramedullary Nail Diameter to Canal Ratio and the Incidence of Non-union

Conditions

Femoral Shaft Fracture

Keywords

intramedullary nail

Outcome Measures

Primary Outcomes (2)

• The ratio between IMN and femoral canal diameter and incidence of union objectively

  We will measure union objectively using x ray (union in 3 or more cortices)

  6 months

• measurement of union clinically

  we will measure the union clinically using visual analog score after 6 weeks.( Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks). then we will test if there is a relation between union and the ratio between femoral canal and IMN diameter.

  6 months

Study Arms (1)

IMN and union

EXPERIMENTAL

putting an intramedullary nail in femoral shaft fractures and finding a relation between the nail diameter to femoral canal diameter and how this will affect healing or predict union

Device: internal fixation by IMN

Interventions

internal fixation by IMN DEVICE

using retrograde or antegrade IMN for femooral fractures fixation using a fit nail to the femoral intramedullary canaland follow up for union

IMN and union

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age (20\_60) years old
• Closed fracture and open grade one
• Midshaft fractures type3\\2 according to the OA classification
• pattern of the fracture (simple transverse,oblique ,spiral)
• Retrograde and Antigrade nail

You may not qualify if:

• Open fractures grade two and three.
• patient with comorbidities eg(DM.HTN…)
• severe osteoporosis with wide medulla .
• patient on regular steroid therapy.
• patient refused to be enrolled in the study

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Millar MJ, Wilkinson A, Navarre P, Steiner J, Vohora A, Hardidge A, Edwards E. Nail Fit: Does Nail Diameter to Canal Ratio Predict the Need for Exchange Nailing in the Setting of Aseptic, Hypertrophic Femoral Nonunions? J Orthop Trauma. 2018 May;32(5):245-250. doi: 10.1097/BOT.0000000000001110.

  PMID: 29401087 BACKGROUND

• Shroeder JE, Mosheiff R, Khoury A, Liebergall M, Weil YA. The outcome of closed, intramedullary exchange nailing with reamed insertion in the treatment of femoral shaft nonunions. J Orthop Trauma. 2009 Oct;23(9):653-7. doi: 10.1097/BOT.0b013e3181a2a337.

  PMID: 19897987 BACKGROUND

• Rudloff MI, Smith WR. Intramedullary nailing of the femur: current concepts concerning reaming. J Orthop Trauma. 2009 May-Jun;23(5 Suppl):S12-7. doi: 10.1097/BOT.0b013e31819f258a.

  PMID: 19390369 BACKGROUND

• Collinge CA, Hymes R, Archdeacon M, Streubel P, Obremskey W, Weber T, Watson JT, Lowenberg D; Members of the Proximal Femur Working Group of the Southeast Trauma Consortium. Unstable Proximal Femur Fractures Treated With Proximal Femoral Locking Plates: A Retrospective, Multicenter Study of 111 Cases. J Orthop Trauma. 2016 Sep;30(9):489-95. doi: 10.1097/BOT.0000000000000602.

  PMID: 27144821 BACKGROUND

Study Officials

• ALY MOHAMADEEN, MD

  Assiut University

  STUDY CHAIR

• mahmoud badran, MD

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

mina kamal, master

CONTACT

+201203380329; minakamalcr7@gmail.com

kamal el gaafary, MD

CONTACT

+201223144899; Kamalelgafary@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: orthopedic resident doctor mina kamal kamel

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 11, 2019
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 16, 2020

Record last verified: 2019-12